Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes

Yale University

Status: Active, not recruiting

Conditions: Type 1 Diabetes; Pancreatitis; Latent Autoimmune Diabetes in Adults

Treatments: Behavioral: Digital Exercise

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06098729

K01DK129441 (U.S. NIH Grant/Contract)

2000035846

Details and patient eligibility

About

The challenges of living with type 1 diabetes often stand in the way of getting enough exercise. Continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. This research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently.

Enrollment: 24 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
• Low exercise levels
• Smartphone ownership
• English literacy
• Under regular care by a healthcare provider
• Home Broadband wireless Internet or cell phone network (≥25 mbps downloads, ≥3 mbps uploads)

Exclusion criteria

• Diabetic ketoacidosis not clearly related to pump site failure in past 6 months
• >1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months
• A1c ≥10.0%
• Resting blood pressure >160mmHg systolic or >100 mmHg diastolic
• Myocardial infarction or angina in past 12 months
• Uncontrolled arrhythmia (e.g., Afib with RVR, new onset Afib, ventricular tachycardia, escape rhythms)
• Congestive heart failure (stage 3 or 4)
• Exercise-induced asthma (not controlled on inhalers)
• Chronic obstructive pulmonary disease (requiring home oxygen)
• Renal failure
• Pregnancy
• Cognitive impairment
• Severe retinopathy or neuropathy.
• Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Digital Exercise

Experimental group

Treatment:

Behavioral: Digital Exercise